The Process Development Scientist conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor.
Work on the Process Monitoring (Continue process verification) for Parenteral and Solid products. Provide support to investigations by participating in the root cause analysis. Own/lead investigations and corrective action implementations.Provides data analysis and interpretation, and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.
Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience.
Ultimate Solutions Corp is an equal opportunity employer.
- Experience working on the Process Monitoring for Parenteral and Solid products.
- Root cause analysis
- Own/lead investigations and corrective action implementations
- Knowledge on parenteral and solid processes (Formulation, Granulation, Filling, Compression, Coating, etc.)
- Statistical knowledge and proficient in the use of Minitab and JMP, R-coding
- Knowledge in data retrieval/data analysis/presentation tools (OsiSoft PI, Spotfire, Smartsheet, Tableau etc), as well as MS Office (including Excel, Word and PowerPoint).
- Excellent technical writing skills.
- Fully bilingual (Spanish/English)